Status:
COMPLETED
NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement
Lead Sponsor:
Jeffrey L Goldberg
Conditions:
Glaucoma, Primary Open Angle
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple pre-clinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like gl...
Eligibility Criteria
Inclusion
- must understand and sign the informed consent
- must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and possible removal, as well as the testing required.
- diagnosis of glaucoma characterized by (a) clinical evidence of progressive RGC dysfunction and degeneration using both visual field and at least one structural modality; (b) residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/100; (c) failure to contain glaucomatous progression with maximally tolerated reduction of intraocular pressure (IOP), OR visual field defect affecting fixation, but not reducing BCVA below 20/100.
Exclusion
- other corneal, lens, optic nerve or retinal disease causing vision loss,
- blind in one eye
- requirement of acyclovir and/or related products during study
- receiving systemic steroids or other immunosuppressive medications.
- pregnant or lactating.
- considered immunodeficient or has a known history of human immunodeficiency virus (HIV)
- on chemotherapy, or a history of malignancy, UNLESS it was treated successfully 2 years prior to inclusion in the trial.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01408472
Start Date
April 1 2011
End Date
October 1 2014
Last Update
August 2 2016
Active Locations (1)
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1
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, United States, 33136